The University of Texas, Anderson Cancer Center, Houston, TX.; The University of Texas Health Science Center, McGovern Medical School, Houston, TX.
The University of Texas, Anderson Cancer Center, Houston, TX.
Semin Radiat Oncol. 2022 Apr;32(2):125-134. doi: 10.1016/j.semradonc.2021.11.003.
In this review, we present the context of older adult (OA) cancer patients within the broader cancer population, including cancer burdens and trial representation. We first describe the proportion of older adults in clinical trials, with studies showing strong evidence that the proportion of OA in cancer trials is much less than the proportion of OA in the overall cancer population. We highlight the lack of generalizability that can lead to challenges in treatment decisions for OA as well as concerns regarding health inequity. We then discuss barriers to OA enrollment related to trial structure and design, physician perspective, and patient and/or caregiver perspective. We expand on this further by outlining these barriers throughout the process of trial design, patient enrollment/trial implementation, and data analysis in post-market settings. We summarize guidelines from national societies, regulatory agencies, and other institutional bodies, then present a compilation of on-the-ground actionable recommendations to address the challenges of clinical trial design, focusing on geriatric assessments and OA-specific trials. We conclude by providing an outline for future directions, noting specifically the potential impact that radiotherapy and radiation oncology may have on clinical trials related to OA patients.
在本次综述中，我们介绍了老年癌症患者在更广泛的癌症人群中的背景情况，包括癌症负担和试验代表性。我们首先描述了临床试验中老年人的比例，研究表明，癌症试验中老年人的比例远低于总体癌症人群中老年人的比例，这一现象存在很大的局限性，可能导致针对老年患者的治疗决策存在挑战，并引发对健康不平等的担忧。接着，我们讨论了与试验结构和设计、医生观点以及患者和/或照护者观点相关的老年患者入组障碍。然后，我们通过在试验设计、患者入组/试验实施和上市后数据分析的各个阶段详细说明这些障碍，进一步阐述了这一点。我们总结了来自国家学会、监管机构和其他机构的指南，然后提出了一系列针对临床试验设计挑战的切实可行的建议，重点关注老年综合评估和专门针对老年患者的试验。最后，我们为未来的方向提供了一个大纲，特别提到了放射治疗和放射肿瘤学可能对老年患者相关临床试验产生的影响。
